(Human) CYP2C9& VKORC1 polymorphism test kit
Warfarinis an orally-taken, coumarin anticoagulant which has been widely used on many diseases in clinic. However, there are significant individual variationsin its effects and adverse reactions, making it difficult to manipulate the dosage. Especially, it is apt to cause hemorrhage and complications during the preliminary stage of anticoagulation therapy using warfarin. It is estimated that among patients taken warfarin, 15.2% reported. occurrence of hemorrhagic side-effects every year, with 3.5% of the cases as fatal hemorrhea. The difference of stable dosage between individuals can be more than 20 folds.
CYP2C9 is an important member of the cytochromeP450 (CYP) enzyme subfamily, accounting for 20% of the total amount of the hepatic microsomeP450protein. It is involved in the hydroxylation metabolism of many medications including anticoagulants, anticonvulsants, hypoglycemic agents, non-steroidal antipyretic analgesic and anti-inflammatory drugs, antihypertensives, and diuretics. Amongst these, warfarin, tolbutamideand phenytoin are medicines with relatively narrow therapeutic index. Variation in the activity of CYP2C9 may lead to significant fluctuation of medications’ concentrations in vivo, or even to severe adverse reactions. Both CYPC2C9*2(rs1799853，C430T，Arg144Cys)and CYP2C9*3(rs1057910，A1075C，Ile359Leu)can cause lower activities of CYP2C9 enzyme. Genetic polymorphism of CYP2C9 results in changing of enzymic activity, and therefore the racial and individual differences of medicine metabolism.
Early in 2007, FDA (Food and Drug Administration) has authorized the revision of product specification of warfarin, recommending CYP2C9 and VKORC1 genotyping before the application of warfarin. The 2013“Technical guidelines for the detection of drug metabolizing enzymes and drug target genes (for Trial Implementation)” has also noted that CYP2C9 and VKORC1 genotypes should be substituted into the formula to calculate the initial dosage of warfarin.
This kit can be applied in the extraction of genomic DNA from human peripheral blood and the subsequent fluorescent quantitative PCR. Through the genotyping of alleles in CYP2C9*2, CYP2C9*3(CYP2C9430C>T, 1075A>C, respectively)and VKORC1(-1639G>A), it assists in the discrimination of patients with enhanced sensitivity to warfarin. Via the determination of patient’s metabolic type, it is possible to choose proper medicine and to adjust the dosage, in order to ensure therapeutic results and to reduce hemorrhagic risks.
Applicable Platforms：ABI 7300 、ABI 7500、ABI viiA7、ABI 7900、ABI Stepone、ABI Stepone plus、LightCycler 2.0、LightCycler、LightCycler480、LightCycler Nano、Chromo 4、opticon 2、CFX96、IQ5
Product registration has been approved by CFDA
Registration number: 国械注准20163401516